BioCryst's Orladeyo® (berotralstat) Receives Recommendation in Ireland for HAE Prophylaxis
核心洞察
The Health Services Executive (HSE) in Ireland has recommended Orladeyo® (berotralstat) for routine prevention of recurrent hereditary angioedema (搜索) (HAE) attacks in eligible patients 12 years and older.
This recommendation grants HAE patients in Ireland access to the first oral, once-daily therapy aimed at reducing the frequency of HAE attacks.
Orladeyo® functions by decreasing the activity of plasma kallikrein (搜索), and it has already been licensed in 44 countries following its European Commission marketing authorization in April 2021.
BioCryst Pharmaceuticals announced that the Health Services Executive (HSE) in Ireland has recommended ORLADEYO® (berotralstat) for the routine prevention of recurrent attacks of hereditary angioedema (搜索) (HAE) in eligible patients 12 years and older. This decision provides HAE patients in Ireland with access to the first oral, once-daily therapy designed to reduce the recurrence of HAE attacks.
Charlie Gayer, chief commercial officer of BioCryst, stated, "The positive HSE recommendation of ORLADEYO broadens access to modern prophylaxis, providing greater choice for prescribing physicians and potentially a better quality of life for HAE patients in Ireland."
The HSE's recommendation follows the European Commission's marketing authorization of ORLADEYO in April 2021. To date, the drug is licensed in 44 countries.
About ORLADEYO® (berotralstat)
ORLADEYO® (berotralstat) is the first and only oral therapy specifically designed to prevent attacks of hereditary angioedema (搜索) (HAE) in adult and pediatric patients 12 years and older. Administered as one capsule daily, ORLADEYO works by decreasing the activity of plasma kallikrein (搜索) to prevent HAE attacks.
Important Safety Information
ORLADEYO is indicated for prophylaxis to prevent attacks of hereditary angioedema (搜索) (HAE) in adults and pediatric patients 12 years and older. It is not indicated for the treatment of acute HAE attacks. Dosages higher than 150 mg once daily are not recommended due to the potential for QT prolongation.
Common adverse reactions (≥10% and higher than placebo) in patients receiving ORLADEYO were abdominal pain, vomiting, diarrhea, back pain, and gastroesophageal reflux disease.
A reduced dosage of 110 mg taken orally once daily with food is recommended in patients with moderate or severe hepatic impairment (Child-Pugh B or C).